Breastfeeding Relaxation Intervention Among Mothers of Preterm Infants in Hospital Sultan Abdul Aziz Shah (HSAAS)

Not Applicable

Recruiting

• Conditions: Behaviour; Psychology; Physiology; Therapy

• Registration Number: NCT06864455
• Lead Sponsor: Universiti Putra Malaysia

Brief Summary

This study is designed to compare the effects of four relaxation interventions on both physiological and psychological outcomes in lactating mothers of preterm infants. The interventions being tested include:

* Guided Imagery Meditation (GIM)

* Religious Recitation (RR)

* Infant Video with Music

* Distraction with News and Media

* A Control session

The primary objectives of the study are to evaluate and compare how these different relaxation techniques influence the physiological and psychological well-being of mothers and identify which intervention is most effective for lactating mothers who deliver prematurely.

The main research questions are:

1. How do different interventions (GIM, RR, Infant Video with Music, Distraction with Media, and Control) affect physiological and psychological outcomes when measured within the same participants?

2. Are there significant differences in physiological and psychological outcomes when participants are exposed to different interventions (GIM, RR, Infant Video with Music, Distraction with Media, and Control) within the same group?

3. Among the interventions, which one demonstrates the most beneficial effects on physiological and psychological outcomes within the same participants?

Study Design:

Each participant will be exposed to five different sessions (one for each intervention), with a gap of 1-2 days between sessions. The interventions will be administered as follows:

* Guided Imagery Meditation (GIM)

* Religious Recitation (RR)

* Infant Video with Music

* Distraction with News and Media

* A Control session

Expected Outcomes:

This study will assess the following physiological and psychological outcomes:

Physiological changes:

* Heart Rate (HR)

* Systolic Blood Pressure (SBP)

* Diastolic Blood Pressure (DBP)

* Fingertip Temperature (FT)

* Breast milk cortisol concentration

Psychological changes:

•. Perceived Relaxation

Detailed Description

The trial aims to recruit 30 mothers of premature infants who are born between 28 and 35 weeks, which falls under the categories of early and mid-preterm. Participants will be recruited among mothers aged between 18 and 49 who are non-smokers, with no medical condition that could affect breastfeeding, and also those who are not taking any psychiatric medication, and those who are not diagnosed with mental illness. This trial also aims to recruit Muslim mothers, since one of the interventions is Religious Recitation which focuses on Qur'anic verses.

The participants will be identified through recent hospital data on premature infants born between 28 to 35 weeks gestation and through a face-to-face approach. The study information sheet will be given to interested mothers. Eligible mothers will be given consent forms after assessing the inclusion and exclusion criteria for mothers and infants. The participants will be enrolled in the study and randomized using a computerized random number generator, where the participants cannot choose which intervention to test first. One person who had no contact with the participants will do randomization five times for each participant since four interventions and controls were involved.

Study Timeline

• Status Verified: 2024-08
• Study Start: 2024-09-17
• Study First Submitted: 2024-11-21
• Study First Submitted QC: 2025-03-03
• Last Update Submitted: 2025-03-03
• Study First Posted: 2025-03-07
• Last Update Posted: 2025-03-07
• Primary Completion: 2025-08-31
• Study Completion: 2026-08-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

• Taking psychiatric medication and being diagnosed with mental illness.
• Mothers are on medication that contradicts breastfeeding (eg: under medication HIV/AIDS)
• Plan to formula feed or mix feeding their infants.
• Mothers of infants with illness that could affect breastfeeding and growth (respiratory issues, gastrointestinal issues, feeding difficulties, neurological disorder, etc)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Heart Rate (BPM)	From enrollment to the end of the 5-session intervention (within 2 weeks).	Pre- and post-measurement of heart rate in beats per minute (BPM).
Systolic Blood Pressure (SBP)	From enrollment to the end of the 5-session intervention (within 2 weeks).	Pre- and post-measurement of systolic blood pressure in millimeters of mercury (mmHg).
Diastolic Blood Pressure (DBP)	From enrollment to the end of the 5-session intervention (within 2 weeks).	Pre- and post- measurement of diastolic blood pressure in millimeters of mercury (mmHg).
Fingertip Temperature (FT)	From enrollment to the end of the 5-session intervention (within 2 weeks).	Pre- and post-measurement of fingertip temperature in degrees Celsius (°C).
Breast Milk Cortisol Level	From enrollment to the end of the 5-session intervention (within 2 weeks).	Pre- and post-measurement of cortisol levels in breast milk, typically expressed in nanograms per milliliter (ng/mL).
Perceived Relaxation (PR)	From enrollment to the end of the 5-session intervention (within 2 weeks).	Pre- and post-measurement of perceived relaxation levels, using a 10 cm Visual Analogue Scale (VAS). The scale ranges from 0 to 10 cm, where 0 cm (on the left) represents "completely unrelaxed" and 10 cm (on the right) represents "completely relaxed." Participants will mark a point on the scale that reflects their level of relaxation at the specified time.

Secondary Outcome Measures

Name	Time	Method
Fat	From enrollment to the end of the 5-session intervention (within 2 weeks).	Pre- and post- measurement of milk fat content in grams per 100 milliliters (g/100 mL)
Carbohydrate	Frame: From enrollment to the end of the 5-session intervention (within 2 weeks)	Pre- and post- measurement of milk carbohydrate content in grams per 100 milliliters (g/100 mL).
Total energy	Frame: From enrollment to the end of the 5-session intervention (within 2 weeks)	Pre- and post-measurement of total energy content in kilocalories per 100 milliliters (kcal/100 mL)

Trial Locations

Locations (1)

Hospital Sultan Abdul Aziz Shah UPM, Serdang Selangor; 🇲🇾 Serdang, Selangor, Malaysia